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Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE).

ABSTRACT: INTRODUCTION:The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context. METHODS AND ANALYSIS:This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted. ETHICS AND DISSEMINATION:This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC. TRIAL REGISTRATION NUMBER:NCT03404583.

SUBMITTER: Cederberg M

PROVIDER: S-EPMC7467509 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE).

Cederberg Matilda M Ali Lilas L Ekman Inger I Glise Kristina K Jonsdottir Ingibjörg H IH Gyllensten Hanna H Swedberg Karl K Fors Andreas A

BMJ open 20200901 9

<h4>Introduction</h4>The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patien ...[more]

PMID: 32873675

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Project description:BackgroundSick leave due to common mental disorders (CMDs) is a public health problem in several countries, including Sweden. Given that symptom relief does not necessarily correspond to return to work, health care interventions focusing on factors that have proven important to influence the return to work process, such as self-efficacy, are warranted. Self-efficacy is also a central concept in person-centered care.ObjectiveThe aim of this study is to evaluate the effects of a person-centered eHealth intervention for patients on sick leave due to CMDs.MethodsA randomized controlled trial of 209 patients allocated to either a control group (107/209, 51.2%) or an intervention group (102/209, 48.8%) was conducted. The control group received usual care, whereas the intervention group received usual care with the addition of a person-centered eHealth intervention. The intervention was built on person-centered care principles and consisted of telephone support and a web-based platform. The primary outcome was a composite score of changes in general self-efficacy (GSE) and level of sick leave at the 6-month follow-up. An intention-to-treat analysis included all participants, and a per-protocol analysis consisted of those using both the telephone support and the web-based platform.ResultsAt the 3-month follow-up, in the intention-to-treat analysis, more patients in the intervention group improved on the composite score than those in the control group (20/102, 19.6%, vs 10/107, 9.3%; odds ratio [OR] 2.37, 95% CI 1.05-5.34; P=.04). At the 6-month follow-up, the difference was no longer significant between the groups (31/100, 31%, vs 25/107, 23.4%; OR 1.47, 95% CI 0.80-2.73; P=.22). In the per-protocol analysis, a significant difference was observed between the intervention and control groups at the 3-month follow-up (18/85, 21.2%, vs 10/107, 9.3%; OR 2.6, 95% CI 1.13-6.00; P=.02) but not at 6 months (30/84, 35.7%, vs 25/107, 23.4%; OR 1.8, 95% CI 0.97-3.43; P=.06). Changes in GSE drove the effects in the composite score, but the intervention did not affect the level of sick leave.ConclusionsA person-centered eHealth intervention for patients on sick leave due to CMDs improved GSE but did not affect the level of sick leave.Trial registrationClinicalTrials.gov NCT03404583; https://clinicaltrials.gov/ct2/show/NCT03404583.

Project description:BackgroundThe number of people with common mental disorders (CMDs), especially stress-related disorders, has increased in several countries, including Sweden, during the past decade. Patients seeking care for long-term stress report severe symptoms. Although person-centred care (PCC) has shown several benefits, studies evaluating the effects of a PCC eHealth intervention on patients with CMDs are scarce.ObjectiveThe aim of this study was to compare levels of self-reported symptoms of burnout between a control group receiving treatment as usual (TAU) and an intervention group receiving TAU with the addition of a person-centred eHealth intervention, in patients on sick leave for CMDs.MethodsThis study reports analysis of a secondary outcome measure from a randomized controlled trial. Patients (n = 209) on sick leave for CMDs were recruited from nine primary health care centres and allocated to either a control group (n = 107) or an intervention group (n = 102). The intervention consisted of phone support and an interactive digital platform built on PCC principles. Self-reported symptoms of burnout were assessed using the Shirom-Melamed Burnout Questionnaire (SMBQ) at baseline and at 3 and 6 months.ResultsOur findings showed changes in SMBQ scores over time in both the control and the intervention group. There was no significant difference in SMBQ scores between the groups; however, a difference in change over time between the groups was observed. The SMBQ scores decreased significantly more in the intervention group than in the controls between 0 and 3 months and between 0 and 6 months. No differences in change between the two groups were seen between the 3- and 6-month follow-ups.ConclusionThis person-centred eHealth intervention for patients on sick leave for CMDs showed a slight initial effect in reducing symptoms of burnout. Taking into account that both groups reported comparable SMBQ scores throughout the study period, the overall effect may be considered limited.Trial registrationThe trial was registered in ClinicalTrials.gov (Identifier NCT03404583). Date of registration: 19/01/2018. https://clinicaltrials.gov/ct2/show/NCT03404583 .

Project description:ObjectivesTo investigate the correspondence between diagnoses on sick leave certificates and diagnoses made in structured psychiatric interviews. Secondary aims were to investigate length of sick leave by diagnoses on sick leave certificates, diagnoses made in structured interviews and symptom severity.DesignObservational study consisting of a secondary analysis of data from a randomised controlled trial and an observational study.SettingThe regions of Stockholm and Västra Götaland, Sweden.Participants480 people on sick leave for common mental disorders.InterventionsParticipants were examined with structured psychiatric interviews and self-rated symptom severity scales.Outcome measures(1) Sick leave certificate diagnoses, (2) diagnoses from the Mini International Neuropsychiatric Interview and the Self-rated Stress-Induced Exhaustion Disorder (SED) Instrument (s-ED), (3) symptom severity (Montgomery-Asberg Depression Rating Scale-self-rating version and the Karolinska Exhaustion Disorder Scale) and (4) number of sick leave days.ResultsThere was little correspondence between diagnoses on sick leave certificates and diagnoses made in structured psychiatric interviews. Many participants on sick leave for SED, anxiety disorder or depression fulfilled criteria for other mental disorders. Most on sick leave for SED (76%) and anxiety disorder (67%) had depression (p=0.041). Length of sick leave did not differ by certificate diagnoses. Participants with SED (s-ED) had longer sick leave than participants without SED (144 vs 84 days; 1.72 (1.37-2.16); p<0.001). More severe symptoms were associated with longer sick leave.ConclusionDiagnoses on sick leave certificates did not reflect the complex and overlapping nature of the diagnoses found in the structured psychiatric interviews. This finding is relevant to the interpretation of information from health data registers, including studies and guidelines based on these data. A result of clinical interest was that more severe symptoms predicted long-term sick leave better than actual diagnoses.

Dataset Information

Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE).

Publications

Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE).

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